Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure the integrity, precision, and compliance of clinical trial data in accordance with study and regulatory requirements, SOPs, and CDISC data standards.

• Supervise data quality for Telix clinical trials.

• Ensure the development of EDC aligns with study requirements.

• Manage data cleaning activities and oversee external data transfers.

• Lead data management tasks for assigned clinical trials from study initiation through database lock and study closure.

• Enhance data collection, flow, and accessibility across both EDC and non-EDC sources.

• Serve as the primary data management subject matter expert for designated trials.

• Supervise EDC build activities, which include DMPs, data review plans, specifications, UAT, and eCRF completion guidelines.

• Oversee data entry, cleaning tasks, and eTMF data management documentation.

• Coordinate with external vendors regarding timelines, deliverables, and data transfers.

• Assist in reviewing data-related deliverables and in the development/review of protocols and SAPs.

• Support audits, inspections, study kick-off meetings, and internal Clinical Data Management initiatives.

• Ensure adherence to GCP, CDISC standards, and relevant regulations.

⛳️ Requirements

• Bachelor’s degree in Health Information Management, Life Sciences, or equivalent professional experience.

• An advanced degree is preferred.

• A minimum of 3 years of experience in clinical trial data management.

• At least 1 year of experience independently managing data management activities for complex global clinical trials.

• Demonstrated ability to oversee multiple vendors and adhere to strict timelines for multiple global complex clinical trials.

• Experience in creating eCRF specifications, edit check specifications, Data Management Plans, Data Review Plans, eCRF Completion Guidelines, UAT plans and test scripts, and data transfer agreements.

• High level of accuracy, strong attention to detail, well-developed organizational skills, prioritization capabilities, sound judgment, and the ability to manage multiple tight and conflicting deadlines.

• Capability to work autonomously as well as collaboratively within a team.

• Familiarity with CDISC, SDMT, CDASH, GCP, and other regulatory requirements for global clinical trials.

• Understanding of the collaborative functions and activities involved in global clinical trials.

• Some travel (20%) may be necessary, potentially including weekends.

• Strong communication, collaboration, adaptability, ethical behavior, resilience, and a commitment to continuous learning.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Hybrid and remote work arrangements are available at Telix.

• Commitment to equal opportunity employment.